Recall Z-0630-2022 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Becton Dickinson & Co.
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
| Date | Feb 9, 2022 (initiated Jan 5, 2022) |
| Status | Open, Classified |
| Reason | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. |
| Root cause | Under Investigation by firm |
| Action | ***UPDATE June 6, 2022**** BD issued a Medical Device Product Advisory letter to Distributors and Users dated July 6, 2022 as a follow-up notification to the voluntary product advisory dated January 5, 2022. In light of this recent complaint, BD is providing additional recommendations to customers to avoid a fire until BD can replace affected units in the field. Letter states: 1. Ensure the contents of this Product Advisory are read and understood by those within your organization. 2. To verify if your BD Veritor" Plus Analyzer(s) is impacted and to complete the acknowledgment distributor res |
| Quantity | 126,952 Analyzers Updated:129, 848 Analyzers |
| Distribution | Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Phili |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Bd, Mar 20, 2018 |